Dr Reddy’s Laboratories Hit With 10 USFDA Observations For Its Hyderabad Facility
A Hyderabad-based formulations manufacturing facility operated by Dr. Reddy’s Laboratories received a Form 483 from the U.S. Food and Drug Administration (FDA) containing 10 observations.
These observations arose after a routine cGMP inspection of the facility (FTO-3) in Bachupally was conducted from October 19-27. Dr. Reddy's disclosed that a Form 483, listing 10 observations, was issued during this inspection. The company intends to address these observations within the provided timeline, according to their filing on Saturday.
Notably, earlier in the same month, the U.S. FDA issued a Form 483 with nine observations after a product-specific pre-approval inspection of Dr. Reddy’s biologics manufacturing facility in Bachupally. The purpose of Form 483 is to inform the company’s management about conditions observed by FDA investigators that may be deemed violations of the Food Drug and Cosmetic Act and related Acts.
The company's stock was down 0.39 per cent at Rs 5,364.55 in the early hours of Monday morning as of 10:44 on BSE.
